Siemens Dimension Vista LOCI 8 Calibrator Recalled for Calibration Failures
Siemens Healthcare Diagnostics is recalling the Dimension Vista LOCI 8 Calibrator due to increased failed calibration events and negative bias in Estradiol assays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential diagnostic errors (negative bias) in patient samples, which is a risk-of-harm scenario where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Vista System LOCI 8 Calibrator, an in vitro diagnostic product used for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System. The recall affects 989 units, with 681 distributed in the United States and 308 distributed outside the US. The specific lot number is 7CD076, and the catalog number is KC646.
The recall was initiated because of an increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using the affected calibrator to calibrate the Estradiol (E2) Assay. The product was distributed worldwide, including in the US (nationwide) and in Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain, and Switzerland.
Healthcare facilities and laboratories should stop using the affected lot of the LOCI 8 Calibrator and contact Siemens Healthcare Diagnostics for further instructions. This recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- CATALOG #(s): KC646 Lot 7CD076- UDI# (01)00842768026492(10)7CD076(17)20180401
Distribution
Distributed nationwide across the United States.
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